Phase 3 Study of ivosidenib (IVO) and azacitidine (AZA) with or without venetoclax in adult patients with newly diagnosed IDH1-mutated AML or MDS/AML ineligible for intensive chemotherapy (EVOLVE-1)
Randomized controlled trial assesses the addition of venetoclax to azacitidine and ivosidenib in IDH1-mutated AML, indicating potential quality of life improvements.
Key Points
Overall survival benefit reported for IDH1-mutated acute myeloid leukemia at 29.3 months with azacitidine and ivosidenib.
Quality of life and event-free survival are primary focus endpoints in this randomized controlled trial for newly diagnosed AML patients.
Patients will receive treatment in 28-day cycles, incorporating azacitidine, ivosidenib, and possibly venetoclax during the trial.
This phase 3 trial highlights an unmet need for effective therapies in patients ineligible for intensive chemotherapy.